The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes

April 28, 2019 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
  • CAPscore >263

Exclusion Criteria:

  • Criteria:

    • Taking any kind of antibiotics two weeks before recruitment;
    • History of alcohol consumption ;
    • pregnancy or lactation;
    • Professional athletes;
    • Other liver disease (viral/etc);
    • High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
    • A history of Cardiovascular disease;
    • Renal disease, Celiac disease, Cirrhosis;
    • History of Upper Gastrointestinal surgery ;
    • A history of hypothyroidism or Cushing's syndrome;
    • History of drug dependence;
    • Body mass index (BMI) ≥35 kg/m2;
    • A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
    • Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
    • Use of weight loss medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: caffeine and chlorogeinc acid
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
Dietary supplement: caffeine and chlorogenic acid
caffeine plus chlorogenic acid
Active Comparator: caffeine
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
Dietary supplement: caffeine
caffeine plus placebo
Active Comparator: chlorogenic acid
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Dietary supplement: chlorogenic acid
chlorogenic acid plus placebo
Placebo Comparator: placebo
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Dietary supplement: placebo
placebo plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic steatosis
Time Frame: 6 months
measured by CAP score using Fibroscan
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose
Time Frame: 6 months
6 months
Glycated hemoglobin (HBA1C)
Time Frame: 6 months
6 months
alanine aminotransferase (ALT)
Time Frame: 6 months
6 months
aspartate aminotransferase (ALS)
Time Frame: 6 months
6 months
High sensitive C reactive protein ( hs- CRP)
Time Frame: 6 months
6 months
gut microbiota
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

October 9, 2016

First Submitted That Met QC Criteria

October 9, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 28, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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